BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number R5C4482 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the female connector of a minicap transfer set had a connection issue; further described as "could not unscrew, despite trying to undo with a clamp".This occurred after use of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation; a patient connector was attached to the female connector of the transfer set.Functional testing including leak, clear passage and clamp function testing were performed with no issues noted.A connection and disconnection was performed by hand using the returned patient connector with no issues or leaks observed.The reported condition of connection issue to female connector was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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